When the Federal Circuit resurrected Amarin’s “skinny label” infringement claims against Hikma last month, it offered some important lessons for drug developers. The precedential decision helps clarify the kinds of...more
Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable. Chevron U.S.A. Inc. v. Natural Resources Defense Council,...more
3/7/2024
/ Abbreviated New Drug Application (ANDA) ,
Chevron Deference ,
Chevron v NRDC ,
Drug Design ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
International Trade Commission (ITC) ,
Medicare Modernization Act ,
Nutritional Supplements ,
Prescription Drugs ,
SCOTUS